Definition of Pharmaco-epidemiology

Pharmaco-epidemiology: Epidemiologists working in the area of pharmacoepidemiology apply epidemiologic reasoning, methods, and knowledge to the study of the uses and effects, beneficial and harmful, of prescription and over the counter drugs, biologics, vaccines, and medical devices in human populations.

Traditionally, pharmacoepidemiology was concerned with post-marketing studies of drug safety. It has since evolved toward a broader focus on epidemiologic questions arising in drug and vaccine development and in health services research more generally, including the observational study of beneficial or intended effects. Studies of intended drug effects are also known as effectiveness studies and include comparative effectiveness research (CER) studies.

Pharmacoepidemiology research is often based on large health care utilization databases using non experimental study of intended and unintended drug effects outside of randomized controlled trials